PARIS, May 22, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced strategic clinical and regulatory milestones for its Edwards PASCAL transcatheter valve repair system.
Today at the EuroPCR annual course in Paris, new 6-month data from the CLASP study of the PASCAL system were presented by Konstantinos Spargias, M.D., from the Hygeia Hospital in Athens, Greece. Patients enrolled in the CLASP study had clinically significant mitral regurgitation (MR) despite optimal medical therapy. The results from treatment with the PASCAL system demonstrated sustained positive outcomes at six months, including 81 percent of patients with mild (1+) or none/trace MR and 98 percent with <</u>2+ MR, with echo core lab adjudication. Patients experienced clinically and statistically significant improvements in functional status, exercise capability and quality of life sustained at six months. These data build on the 30-day CLASP study results presented last month at the German Society of Cardiology (DGK), which also demonstrated significant reduction in MR and improvements in quality of life measures. At 30 days, the major adverse events rate was low at 6.5 percent, and there was no incidence of stroke or myocardial infarction (MI).
In addition, the U.S. Food and Drug Administration (FDA) has approved CLASP IIF, a prospective, multicenter, randomized, controlled pivotal trial studying the PASCAL system. The trial is designed to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL system compared with the Abbott MitraClip device, for the treatment of moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) in symptomatic heart failure patients. The study is expected to begin enrolling in the next few months. Edwards already has underway the CLASP IID U.S. pivotal trial, which is currently enrolling patients with symptomatic primary mitral regurgitation.
"Each of these milestones, including the positive CLASP study results, the approval of the pivotal CLASP IIF trial and the pivotal CLASP IID trial already enrolling, support our strategy to lead and transform the treatment of patients with mitral valve disease," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "We look forward to the ongoing follow-up on these clinical and regulatory milestones to further validate these early results."
The PASCAL system is one of multiple transcatheter repair or replacement therapies under development by Edwards that are designed to address mitral and tricuspid valve diseases. It represents the culmination of 20 years of innovation by Edwards to develop a novel, differentiated and advanced platform for patients in need. The company is building on a long history of knowledge, experience and commitment to advance transformative therapies and develop a robust body of clinical evidence.
The PASCAL system received CE Mark and is available commercially in Europe; it is not approved in the United States.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.edwards.com and follow us on Twitter @EdwardsLifesci.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements by Mr. Zovighian, expectations for trial enrollment, and statements regarding expected product benefits and the company's strategy to lead and transform patient care. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unexpected delays or changes in the product introduction, unanticipated outcomes of longer term clinical experience with the product, or unanticipated manufacturing, legal, quality or regulatory delays or issues. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2018. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo and PASCAL are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and/or its subsidiaries.
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